Automatic analysis device and automatic analysis method

ABSTRACT

The automatic analysis device  100  is provided with: a specimen dispensing mechanism  101  that dispenses subject blood plasma and/or normal blood plasma to be added to correct the coagulation time of the subject blood plasma, into a plurality of specimen containers  103 ; reaction containers  104  that contain the subject blood plasma and/or the normal blood plasma; a reagent dispensing mechanism  106  that dispenses a reagent into the reaction containers  104 ; and a detecting unit  113  which applies light from a light source  115  to the subject blood plasma and/or the normal blood plasma to which the reagent is added in the reaction containers  104 , and which measures the coagulation time on the basis of the obtained scattered light and/or transmitted light.

TECHNICAL FIELD

The present invention relates to an automatic analysis device forcarrying out qualitative/quantitative analyses of biological samplessuch as blood and urine, and particularly relates to an automaticanalysis device and an automatic analysis method which are suitably usedfor blood coagulation/hemostasis tests.

BACKGROUND ART

Blood coagulation tests are carried out in order to recognize thepathology of a blood coagulation fibrinolysis system, to diagnose adisseminated intravascular coagulation syndrome (DIC), to confirm athrombus treatment effect, and to diagnose hemophilia. In particular, asfor blood coagulation time measurement, a time until a fibrin clot isformed after a specimen and a reagent are mixed with each other(hereinafter, referred to as a blood coagulation time) is measured. In acase where there is a congenital or acquired abnormality, the bloodcoagulation time is prolonged.

However, if the blood coagulation time is merely measured, it is notpossible to determine whether the cause of the abnormality is activitydegradation resulting from blood coagulation factor deficiency(deficiency type), or whether the cause of the abnormality is activitydegradation resulting from blood coagulation reaction inhibition(inhibitor type) of an antibody with respect to a component configuringa blood coagulation system or a component in a blood coagulation timemeasurement reagent.

On the other hand, in a case of treatment, it is necessary to clarifythe cause of the abnormality, since a treatment policy varies dependingon whether the cause of the prolonged blood coagulation time is thedeficiency type or the inhibitor type.

As a method for determining the cause of the prolonged blood coagulationtime, there is a cross mixing test (also called a blood coagulationcorrection test or a cross-flow-over test) using added normal bloodplasma. In the cross mixing test, the normal blood plasma is added tosubject blood plasma, and a correction degree of the blood coagulationtime is graphed and determined. As the most representative applicationexample of the cross mixing test, a factor of prolonged APTT isdetermined. However, in some cases, items such as prothrombin time (PT),dilute PT (dPT), dilute APTT (dAPTT), kaolin coagulation time (KCT), anddilute Russell's viper venom time (dRVVT) are performed.

Incidentally, although APTT is a major item that can be performed inmost facilities for carrying out the blood coagulation tests, a currentsituation hardly shows that the cross mixing test is frequently carriedout. In a case where APTT cannot be performed in the facilities and anoutsourcer is requested to carry out the test, it takes time to receiveresults, thereby leading to delayed discovery and delayed treatmentstart of severe diseases such as haemophilia. The reason why thissituation occurs is that preparation and incubation work of a specimenis complicated and interpretation of the result is not clear.Consequently, the work requires a tester's skill job.

In order to solve the above-described problem, PTL 1 proposes thefollowing technique. According to PTL 1, each blood coagulation time ismeasured for subject blood plasma alone, normal blood plasma alone, anda sample (mixed blood plasma) obtained by mixing the subject bloodplasma and the normal blood plasma at least at one mixing ratio. Adifference is obtained between a lower area (A) of a line graph in whichan obtained measured value is plotted and a lower area (B) of a straightline connecting measured values of the subject blood plasma alone andthe normal blood plasma alone. An area ratio (A−B)/(B) of the differenceis compared with a predetermined reference area ratio Y. Based on thecomparison result, it is determined whether the cause is the inhibitortype or the deficiency type.

CITATION LIST Patent Literature

PTL 1: Pamphlet of International Publication No. WO2009/153964

SUMMARY OF INVENTION Technical Problem

However, PTL 1 does not disclose a method for automated mixing of thesubject blood plasma and the normal blood plasma. In a case the mixingis prepared by a hand using method, work may be complicated, or theaccuracy of the mixing ratio of the obtained mixed blood plasma may varydepending on a worker's skill level.

Therefore, the present invention aims to provide an automatic analysisdevice and an automatic analysis method which enable automatedpreparation of the mixed blood plasma obtained by mixing the subjectblood plasma and the normal blood plasma at a prescribed mixing ratio.

Solution to Problem

In order to solve the above-described problem, according to the presentinvention, there is provided an automatic analysis device which includesa specimen container holding unit that accommodates and holds aplurality of specimen containers, a specimen dispensing mechanism thatdispenses subject blood plasma and/or normal blood plasma to be added tocorrect a coagulation time of the subject blood plasma, to a vacantspecimen container in the plurality of specimen containers accommodatedin the specimen container holding unit, a reaction container in whichthe subject blood plasma alone, the normal blood plasma alone, and mixedblood plasma obtained by mixing the subject blood plasma and the normalblood plasma at least at one mixing ratio are prepared inside thespecimen container, and in which the subject blood plasma, the normalblood plasma, and the mixed blood plasma which are prepared aredispensed by the specimen dispensing mechanism, a reagent dispensingmechanism that dispenses a reagent to the reaction container, and ameasurement unit that irradiates the subject blood plasma to which thereagent inside the reaction container is added, the normal blood plasmaand/or the mixed blood plasma with light emitted from a light source,and that measures the coagulation time, based on obtained scatteredlight and/or transmitted light.

In addition, according to the present invention, there is provided anautomatic analysis method of an automatic analysis device which has atleast a specimen container holding unit that accommodates and holds aplurality of specimen containers, a specimen dispensing mechanism, areagent dispensing mechanism, and a measurement unit. The automaticanalysis method includes causing the specimen dispensing mechanism todispense subject blood plasma and/or normal blood plasma to be added tocorrect a coagulation time of the subject blood plasma, to a vacantspecimen container in a plurality of specimen containers accommodated inthe specimen container holding unit, preparing the subject blood plasmaalone, the normal blood plasma alone, and mixed blood plasma obtained bymixing the subject blood plasma and the normal blood plasma at least atone mixing ratio, inside the specimen container, causing a reactioncontainer to contain the subject blood plasma, the normal blood plasma,and the mixed blood plasma which are prepared, and causing the reagentdispensing mechanism to dispense a reagent to the reaction container,and irradiating the subject blood plasma to which the reagent inside thereaction container is added, the normal blood plasma and/or the mixedblood plasma with light emitted from a light source, and measuring thecoagulation time, based on obtained scattered light and/or transmittedlight.

Advantageous Effects of Invention

According to the present invention, it is possible to provide anautomatic analysis device and an automatic analysis method which enableautomated preparation of mixed blood plasma obtained by mixing subjectblood plasma and normal blood plasma at a prescribed mixing ratio.

Problems, configurations, and advantageous effects other than thosedescribed above will be clarified by the description of the followingembodiments.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an overall schematic configuration diagram of an automaticanalysis device in Embodiment 1 according to an embodiment of thepresent invention.

FIG. 2 is a schematic view of a cross mixing test.

FIG. 3 is a flowchart illustrating a process flow of the automaticanalysis device illustrated in FIG. 1.

FIG. 4 illustrates a display example of an operation screen when ameasurement is requested in the cross mixing test.

FIG. 5 illustrates a display example of an operation screen when ameasurement is requested in the cross mixing test.

FIG. 6 is a view illustrating a state where normal blood plasma isaspirated by a specimen dispensing mechanism.

FIG. 7 is a view illustrating a state where subject blood plasma isaspirated by the specimen dispensing mechanism.

FIG. 8 is a view illustrating a state where the normal blood plasma orthe subject blood plasma is discharged by the specimen dispensingmechanism.

FIG. 9 is a view illustrating a state where mixed blood plasma isstirred by a stirring mechanism.

FIG. 10 is a view illustrating a result of the cross mixing test carriedout by the automatic analysis device according to Example 1.

FIG. 11 is an overall schematic configuration diagram of an automaticanalysis device in Example 2 according to another embodiment of thepresent invention.

FIG. 12 is a view for describing a transportation procedure of specimenracks in the automatic analysis device illustrated in FIG. 11.

FIG. 13 is a view for describing a transportation procedure of specimenracks during a cross mixing test in the automatic analysis deviceillustrated in FIG. 11.

FIG. 14 is a view for describing a specimen dispensing position duringthe cross mixing test in the automatic analysis device illustrated inFIG. 11.

FIG. 15 is a flowchart illustrating a process flow of an automaticanalysis device in Example 3 according to another embodiment of thepresent invention.

FIG. 16 illustrates a display example of an operation screen when ameasurement is requested in a cross mixing test according to Example 3.

FIG. 17 is a flowchart illustrating a process flow of an automaticanalysis device in Example 4 according to another embodiment of thepresent invention.

FIG. 18 is a timing chart illustrating an operation of the automaticanalysis device according to Example 4.

FIG. 19 is a flowchart illustrating a process flow of an automaticanalysis device in Example 5 according to another embodiment of thepresent invention.

FIG. 20 is a flowchart illustrating a process flow of an automaticanalysis device in Example 6 according to another embodiment of thepresent invention.

FIG. 21 illustrates a display example of an operation screen when ameasurement is requested in a cross mixing test according to Example 6.

FIG. 22 is a view illustrating normal blood plasma alone, subject bloodplasma alone, and mixed blood plasma obtained at five different mixingratios.

FIG. 23 is a view illustrating normal blood plasma alone, subject bloodplasma alone, and mixed blood plasma obtained at three different mixingratios.

FIG. 24 is a view illustrating normal blood plasma alone, subject bloodplasma alone, and mixed blood plasma obtained at one mixing ratio.

DESCRIPTION OF EMBODIMENTS

In the present specification, “subject blood plasma” includes both bloodplasma of an inpatient or outpatient and blood plasma of a subject inmedical examinations. In addition, in the present specification, “normalblood plasma”, “subject blood plasma”, and “mixed blood plasma mixed atvarious mixing ratios” are collectively referred to as a specimen formeasuring a blood coagulation time, in some cases. In addition, in thepresent specification, a “general specimen” is a specimen of thesubject.

FIG. 2 is a schematic view of a cross mixing test. Normal blood plasmais added to subject blood plasma, and both of these are mixed to preparea specimen so that ratios of the normal blood plasma are respectively0%, 10%, 20%, 50%, 80%, 90%, and 100%, thereby measuring APTT. Arelationship between a measurement result (blood coagulation time) andthe ratios of the normal blood plasma is plotted, thereby preparing agraph. As illustrated in FIG. 2, a horizontal axis represents a normalblood plasma ratio (%), and a vertical axis represents an activatedpartial thromboplastin time (APTT: blood coagulation time). For example,in a deficiency type as illustrated by a solid line (a) in FIG. 2, APTTprolongation is corrected by adding the normal blood plasma, and thedeficiency type shows a pattern protruding downward. On the other hand,in an inhibitor type as illustrated by a solid line (b) in FIG. 2, evenif the normal blood plasma is added, APTT prolongation is less likely tobe corrected, and the inhibitor type shows a pattern protruding upward.However, reaction of an inhibitor to a factor VIII depends on a time anda temperature. Accordingly, reaction immediately after blending (mixing)(hereinafter, referred to as immediate reaction) does not clearly showthe shape protruding upward. Reaction after incubating for a prescribedperiod of time at 37° C. (hereinafter, referred to as delayed reaction)shows the shape protruding upward in some cases.

Therefore, measurements for both the immediate reaction and the delayedreaction are recommended in the cross mixing test.

Hereinafter, embodiments according to the present invention will bedescribed with reference to the drawings.

Example 1

FIG. 1 is an overall schematic configuration diagram of an automaticanalysis device in Example 1 according to an embodiment of the presentinvention. Here, a flow of a basic blood coagulation test will bedescribed with reference to FIG. 1. However, the embodiment is notlimited to the following example.

An automatic analysis device 100 is schematically configured to includea specimen dispensing mechanism 101, a specimen disc 102, a reagentdispensing mechanism 106, a reagent disc 107, a reaction container stockunit 111, a reaction container transport mechanism 112, a detecting unit113, a reaction container disposal unit 117, an operation unit 118, astorage unit 119, and a control unit 120.

The specimen dispensing mechanism 101 aspirates a specimen contained inthe specimen container 103 disposed in the specimen disc 102 rotatingclockwise and counterclockwise, and discharges the specimen to thereaction container 104 accommodated in the reaction container stock unit111. The specimen dispensing mechanism 101 includes a specimendispensing probe 101 a in a distal portion, and performs an aspirationoperation and a discharge operation of the specimen by operating aspecimen syringe pump 105 controlled by the control unit 120.

The reagent dispensing mechanism 106 aspirates the reagent contained inthe reagent container 108 disposed in the reagent disc 107, anddischarges the reagent to the reaction container 104 accommodated in thereaction container stock unit 111. The reagent dispensing mechanism 106includes a reagent dispensing probe 106 a in a distal portion, andperforms an aspiration operation and a discharge operation of thereagent by operating a reagent syringe pump 110 controlled by thecontrol unit 120.

In addition, the reagent dispensing mechanism 106 is internally equippedwith a reagent temperature raising mechanism 109. The temperature of thereagent aspirated by the reagent dispensing mechanism 106 is raised toan appropriate temperature (predetermined temperature) by the reagenttemperature raising mechanism 109 controlled by the control unit 120.

The reaction container transport mechanism 112 transports and installsthe reaction container 104 accommodated in the reaction container stockunit 111. The reaction container transport mechanism 112 grips thereaction container 104 and pivots in an arc shape in a horizontal plane.In this manner, the reaction container 104 is transported from thereaction container stock unit 111, and is installed in the reactioncontainer installation unit 114 of the detecting unit 113.

The detecting unit 113 has at least one or more reaction containerinstallation units 114 for mounting the reaction container 104 thereon.The detecting unit 113 measures light intensity of the specimen insidethe reaction container 104 inserted into the reaction containerinstallation unit 114. Although the present embodiment shows a casewhere one detecting unit 113 is provided, a configuration having aplurality of detecting units 113 may be adopted. An example of detectionprinciples in the detecting unit 113 will be described below. Lightirradiated from a light source 115 is scattered by a reaction solutioninside the reaction container 104. A detector (light receiving unit) 116is configured to include a photodiode. The detector 116 receives thescattered light scattered by the reaction solution (specimen) inside thereaction container 104, and performs light/electric conversion, therebyoutputting a light measurement signal indicating the intensity of thereceived scattered light to an A/D converter 121. The measurement signalof the scattered light subjected to A/D conversion in by the A/Dconverter 121 is input to the control unit 120 via an interface 122. Theoperation of the detecting unit 113 is controlled by the control unit120. Here, the control unit 120 is configured to include an analysisoperation control unit 120 a and a calculation unit 120 b. For example,the analysis operation control unit 120 a and the calculation unit 120 bare realized by a processor such as a CPU, read various programs storedin a ROM or the storage unit 119 (not illustrated), and execute the readprogram, thereby performing control and calculation.

That is, the analysis operation control unit 120 a controls the specimendispensing mechanism 101 and the specimen disc 102 so as to dispense thespecimen. In addition, the analysis operation control unit 120 acontrols the reagent dispensing mechanism 106 and the reagent disc 107so as to discharge the reagent to the specimen inside the reactioncontainer 104. Furthermore, the analysis operation control unit 120 acontrols the operation of the automatic analysis device such as themovement of the reaction container 104 and the disposal of the reactioncontainer 104.

Based on a result of comparison between a signal value obtained from ameasurement value of the light intensity changing in a time-dependentmanner according to a degree of mixed reaction of the specimen and thereagent and a predetermined determination threshold value, thecalculation unit 120 b performs a measurement process for measuring areaction time of the specimen. The calculated coagulation time is outputto a display unit 118 c, and is stored in the storage unit 119. Thecoagulation time as the calculation result may be printed out by aprinter 123 via the interface 122.

The detector 116 is not limited to a configuration which receives thescattered light scattered by the reaction solution (specimen) inside thereaction container 104. For example, the detector 116 may be configuredto detect the intensity of transmitted light which passes through thereaction solution (specimen) inside the reaction container 104. Inaddition, the detector 116 may use both a detecting method of thescattered light and a detecting method of the transmitted light.Furthermore, in addition to the above-described configurations, thedetector 116 may utilize viscosity.

The reaction container transport mechanism 112 grips the reactioncontainer 104 which is completely measured, and discards the reactioncontainer 104 to the reaction container disposal unit 117.

In order to improve the throughput, a configuration having no detectormay be adopted which includes an incubator 124 for warming the specimenbefore a measurement start reagent is added.

Analysis items of the specimen analyzed by the automatic analysis device100 are input from the operation unit 118 to the control unit 120 via akeyboard 118 b serving as an input unit or an operation screen displayedon the display unit 118 c. A configuration may be adopted which uses agraphical user interface (GUI) for inputting the analysis items bycausing a mouse 118 a to perform a pointing operation on the analysisitems displayed on the display unit 118 c with a pointer.

For the sake of convenience in illustrating all configuration elements,FIG. 1 illustrates an arrangement where the reaction container stockunit 111, the specimen disc 102, and the reagent disc 107 are separatedfrom each other. However, the specimen disc 102 and the reactioncontainer stock unit 111 are arranged within a range of an arc-shapedmovement trajectory inside a horizontal plane of the specimen dispensingprobe 101 a configuring the specimen dispensing mechanism 101. Thereagent disc 107 and the reaction container stock unit 111 are arrangedwithin a range of an arc-shaped movement trajectory inside thehorizontal plane of the reagent dispensing probe 106 a configuring thereagent dispensing mechanism 106. Therefore, in a case where all ofthese are viewed from above, the specimen disc 102, the reactioncontainer stock unit 111, and the reagent disc 107 are arranged in asubstantially triangular shape.

Subsequently, a request for the cross mixing test and a preparationmethod of the specimen in the automatic analysis device 100 of thisembodiment will be described in detail below. FIG. 3 is a flowchartillustrating a process flow of the automatic analysis device illustratedin FIG. 1, and particularly illustrates a flow of the preparation methodof the specimen when the measurement is requested in the cross mixingtest.

First, the automatic analysis device 100 receives the request for thecross mixing test (Step S101). A method of receiving the requestincludes a method of receiving the request via a network system using ahost computer and a method of receiving a cross mixing test measurementrequest input by an operator who requests the measurement requestthrough the operation unit 118. In the following description, a casewhere the measurement request is input via the operation screen will bedescribed as an example.

FIGS. 4 and 5 illustrate a display example of the operation screendisplayed on the display unit 108 c configuring the operation unit 118when the measurement is requested in the cross mixing test. Asillustrated in FIG. 4, the cross mixing test measurement request screen(operation screen) has a region for displaying a type of the specimen,that is, any one of a general specimen, an urgent specimen, and control.FIG. 4 illustrates that the cross mixing measurement of the generalspecimen is requested. In addition, the cross mixing measurement requestscreen (operation screen) has a test item selection/designation region127. An operator can designate an item for performing the cross mixingtest from the test item selection/designation region 127 through theoperation screen. The example illustrated in FIG. 4 shows a state wherean item APTT is selected and designated. In addition, the operationscreen has a region in which a normal blood plasma ratio can beselectively designated. The example illustrated in FIG. 4 shows a statewhere seven conditions of the normal blood plasma ratios of 0%, 10%,20%, 50%, 80%, 90%, and 100% are all set. Here, the normal blood plasmaratios to be set are not limited to the seven conditions illustrated inFIG. 4. For example, it is possible to select three or more conditionsincluding 0% and 100%. That is, as long as the subject blood plasmaalone, the normal blood plasma alone, and the mixed blood plasma of atleast one mixing ratio are set, other mixing ratios can be optionallyset.

As illustrated in FIG. 4, if the measurement item and the normal bloodplasma ratio are set, the analysis operation control unit 120 acalculates the normal blood plasma amount and the subject blood plasmaamount which are required for measurement, and determines each of thenormal blood plasma amount and the subject blood plasma amount which aredifferent depending on the conditions, thereby controlling the operationof the specimen dispensing mechanism 101. In this case, as illustratedin FIG. 5, the operator is informed by displaying the required normalblood plasma amount and the required subject blood plasma amount on thedisplay unit 118 c. Since the operator can recognize the required bloodplasma amount, there is an advantageous effect in that the burden of theoperator calculating the required amount is reduced and the operator canbe prevented from lacking blood plasma amount during the preparation.Here, in FIG. 5, the operator designates the installation position ofthe normal blood plasma, the subject blood plasma, and the vacantspecimen container, but the device may be controlled so as to designatethe installation position. In addition, FIG. 5 illustrates a state where“100” is set as the installation position of the normal blood plasma,“101” is set as the installation position of the subject blood plasma,and “102” is set as a start position of the vacant specimen container.Here, each position represents a position of the specimen container 103in the specimen disc 102. It is not necessarily specified by onlynumbers. For example, a combination of alphabets and numbers may specifythe position of the specimen container 103.

In addition, in a case where the request is received from the networksystem using the host computer, the analysis can be performed withoutsetting the measurement item or the measurement condition.

In a state illustrated in FIG. 5, if a “start” button is pressed (StepS102), the normal blood plasma amount, the subject blood plasma amount,and the presence of the vacant specimen container are confirmed (StepS103). Here, the vacant specimen container is a disposable and closablecontainer having an individual identification medium. The individualidentification medium is used for identifying the specimen. For example,a barcode or RFID is used. In the individual identification medium ofthe subject specimen, in addition to a specimen ID for identifying thespecimen, measurement request information is included. The individualidentification medium affixed to the vacant specimen container is usedfor managing the mixed blood plasma after an optional number is assignedand the normal blood plasma and the subject blood plasma are mixed. Inorder to confirm the normal blood plasma amount, the subject bloodplasma amount, the presence of the vacant specimen container, a liquidlevel detection function of the specimen dispensing mechanism 101 isused. That is, the specimen dispensing probe 101 a disposed in thedistal end of the specimen dispensing mechanism 101 detects a liquidlevel by utilizing a change in electric characteristics such aselectrostatic capacity and a resistance value which vary when an objectcomes into contact with or comes close to the liquid level.Alternatively, a configuration may be adopted in which an image iscaptured using an imaging function (sensor such as CCD, CMOS, and PMT)by a small camera so as to calculate a liquid amount from the height ofthe liquid level. In the following description, a case of using theliquid level detection function of the specimen dispensing mechanism 101and using the barcode as the individual identification medium will bedescribed as an example.

When the subject specimen and the vacant specimen container which areinstalled at the designated position in FIG. 5 pass in front of thereading unit 125 by the rotation of the specimen disc 102 rotatingclockwise and counterclockwise, the barcode serving as the individualidentification medium of the subject specimen is read. The request itemfor the subject specimen specified by the read barcode is verified, andthe normal blood plasma ratio or the original subject specimeninformation prepared in the installed vacant specimen container isverified with an ID of each mixed blood plasma. Subsequently, asillustrated in FIG. 6, in the specimen container 103 in the specimendisc 102, the specimen container 103 a filled with the normal bloodplasma is moved to a dispensing position of the specimen dispensingmechanism 101, and the normal blood plasma amount is confirmed using theliquid level detection function of the specimen dispensing probe 101 a.In a similar manner, the specimen container 103 b filled with thesubject blood plasma is moved to the dispensing position, and thesubject blood plasma amount is confirmed using the liquid leveldetection function of the specimen dispensing probe 101 a (FIG. 7).Furthermore, as for the vacant specimen container, in a case where theliquid level detection function of the specimen dispensing probe 101 adetects that there is no contact with the liquid surface and thespecimen container comes into contact with the bottom (abnormal descentdetection), it is recognized that the installed specimen container isvacant.

Referring back to FIG. 3, in Step S104, as a result of the containerinstallation check, the normal blood plasma amount and the subject bloodplasma amount are less than the required amount, or the required numberof vacant specimen containers is not installed at the predeterminedposition. In this case, the mixed blood plasma preparation is canceled,and a system alarm is displayed (Step S105). In this manner, the bloodplasma is further dispensed to a place where the blood plasma isinsufficient during the measurement or a place where the vacant specimencontainer is not installed, that is, the specimen container where thespecimen (the normal blood plasma, the subject blood plasma, or themixed blood plasma) is previously dispensed. Accordingly, it is possibleto avoid the risk of contaminating the specimen disc 102.

In Step S104, in a case where the normal blood plasma amount and thesubject blood plasma amount are prepared more than necessary and it canbe confirmed that the required number of vacant specimen containers isinstalled, the normal blood plasma starts to be dispensed to the vacantspecimen container (Step S106).

Here, a dispensing operation of the normal blood plasma will bedescribed. Rotation of the specimen disc 102 rotating clockwise andcounterclockwise causes the specimen container 103 a filled with thenormal blood plasma to move to the dispensing position, and causes thespecimen dispensing mechanism 101 to aspirate the normal blood plasma(FIG. 6). The example illustrated in FIG. 6 shows a case where thespecimen disc 102 is rotated counterclockwise in a stepwise manner. Amoving distance in each step is equivalent to a pitch of the twospecimen containers 103 arranged adjacent to each other. In this manner,the reading unit 125 reads the barcode affixed to the specimen container103 as described above so as to identify the specimen ID. Thereafter,the specimen container 103 is moved along the rotation direction of thespecimen disc 102, and is positioned (at the specimen dispensingposition) immediately below the specimen dispensing mechanism 101located in front of the reading unit 125. That is, each of the specimencontainers 103 is always positioned at the dispensing position after thespecimen ID is identified by the reading unit 125.

Next, the specimen container 103 positioned at the dispensing positionby the stepwise rotation of the specimen disc 102 is the specimencontainer 103 b filled with the subject blood plasma (FIG. 7).Accordingly, the specimen dispensing mechanism 101 does not dischargethe normal blood plasma aspirated by the specimen dispensing probe 101a. Subsequently, the specimen container positioned at the dispensingposition is the vacant specimen container 103 c, and discharges thenormal blood plasma aspirated into the specimen dispensing probe 101 a(FIG. 8). This operation is repeatedly performed, and the normal bloodplasma is dispensed to vacant specimen containers 103 d to 103 i. If thenormal blood plasma is completely dispensed (Step S107), the subjectblood plasma is subsequently dispensed (Step S108).

In the dispensing operation of the subject blood plasma in Step S108,first, the specimen container 103 b filled with the subject blood plasmais positioned at the dispensing position by the rotation of the specimendisc 102, and the subject blood plasma is aspirated by the specimendispensing probe 101 a of the specimen dispensing mechanism 101 (FIG.7). Subsequently, the specimen container positioned at the dispensingposition by the rotation of the specimen disc 102 is the specimencontainer 103 c from which the normal blood plasma is discharged in StepS106. The specimen dispensing probe 101 a discharges the aspiratedsubject blood plasma to the specimen container 103 c (FIG. 8). In thesame procedure, the subject blood plasma is dispensed to the specimencontainers 103 d to 103 i by the specimen dispensing probe 101 a. Thisoperation is repeatedly performed until the subject blood plasma is alldispensed (Step S109).

In Step S106 and Step S108, the discharge amount of the normal bloodplasma and the subject blood plasma which are discharged to each of thespecimen containers 103 c to 103 i by the specimen dispensing probe 101a configuring the specimen dispensing mechanism 101 corresponds to thenormal blood plasma ratio set by the operation screen illustrated inFIG. 4, for example.

Referring back to FIG. 3, in Step S110, as illustrated in FIG. 9, themixed blood plasma of the normal blood plasma and the subject bloodplasma which are dispensed into the specimen container 103 c positionedimmediately below a stirring mechanism 126 is stirred by the stirringmechanism 126. Here, for example, as illustrated in FIG. 9, the stirringmechanism 126 performs the stirring operation in such a way that astirring blade or a spatula-shaped rod disposed in the distal end isrotated while being dipped into the mixed blood plasma inside thespecimen container 103 c. The stirring mechanism 126 is not limited to asystem which rotates the stirring blade or the spatula-shaped rod. Forexample, a configuration may be adopted in which the mixed blood plasmain the specimen container is irradiated with ultrasonic waves andstirred. Alternatively, a configuration may be adopted in which thespecimen disc 102 is rotated in the forward and reverse directions(clockwise and counterclockwise). Alternatively, a configuration may beadopted in which the mixed blood plasma is stirred using dischargepressure when the normal blood plasma or the subject blood plasma isdischarged from the specimen dispensing probe 101 a to the specimencontainer 103, that is, discharge pressure of the specimen syringe pump105.

In this way, in the automatic analysis device 100 according to thepresent embodiment, the mixed blood plasma having various normal bloodplasma ratios set by the above-described operation screen illustrated inFIG. 4 can be automatically prepared by the specimen dispensingmechanism 101 and the stirring mechanism 126.

In FIG. 3, a configuration is adopted in which the subject blood plasmais dispensed (Step S108) after the normal blood plasma is dispensed(Step S106). However, without being limited thereto, a configuration maybe adopted in which the mixed blood plasma is prepared by dispensing thenormal blood plasma after the subject blood plasma is dispensed. Inaddition, from a viewpoint of preventing the contamination of the normalblood plasma and the subject blood plasma, the normal blood plasma andthe subject blood plasma are independently dispensed. However, theembodiment is not limited thereto. For example, in a case where thespecimen dispensing mechanism 101 is sufficiently cleaned and there isno worry about the contamination, it is possible to produce (prepare)the mixed blood plasma one by one. In this case, after the requiredamount of the normal blood plasma is dispensed to the vacant specimencontainer 103 c, the required amount of the subject blood plasma isdispensed. After the mixed blood plasma of the specimen container 103 cis produced, the mixed blood plasma is sequentially produced for eachvacant specimen container so as to produce the mixed blood plasma of thevacant specimen container 103 d.

In addition, when two types of specimen are dispensed, when theprocesses are completed until Step S109 in FIG. 3, a screen indicatingthe preparation completion is displayed on the display unit 118 c. Thespecimen container containing the prepared specimen is closed andstirred by the operator. In this manner, the specimen container may beinstalled again on the specimen disc 102. In this case, since it is notnecessary to provide the specimen stirring mechanism 126, the device candecrease in size.

After the specimen is prepared, the analysis is performed using sevenmixed blood plasmas prepared on the specimen containers 103 c to 103 i.In this way, the measurement to be carried out immediately after thespecimen is prepared is defined as an immediate-type measurement. InStep S111 of FIG. 3, the barcode affixed to the specimen containers 103c to 103 i containing the mixed blood plasma having seven mutuallydifferent normal blood plasma ratios is read by the reading unit 125.The reading unit 125 specifies each normal blood plasma ratio of thenormal blood plasma alone, the subject blood plasma alone, and fivemixing ratios, that is, 10, 20, 50, 80, and 90% of the mixed bloodplasma ratio. Thereafter, the process proceeds to Step S112. In StepS112, the specimen contained in each of the specimen containers 103 c to103 i is dispensed to the different reaction containers 104 to becontained inside the reaction container stock unit 111 by the specimendispensing mechanism 101. Thereafter, each reaction container 104 ismoved to the detecting unit 113 by the reaction container transportmechanism 112, the reaction container 104 is set in the reactioncontainer installation unit 114 as described above, and the measurementsignal indicating the intensity of the scattered light and/or thetransmitted light is detected. Here, the specimen container of the sevenprepared specimens has a function which can verify the measurementresult by recognizing the normal blood plasma ratio verified in StepS103 and the subject specimen ID.

Incidentally, this cross mixing test is different from that of theordinary analysis as follows. A plurality of (in this case, seven) APTTcoagulation times are calculated for one subject specimen, and one graphis prepared so as to be used for the diagnosis. For example, in order todisplay the result after the immediate-type measurement is completed,the operation unit 118 c displays a graph obtained by plotting that thenormal blood plasma ratio of each mixed blood plasma is set as thehorizontal axis as illustrated by a solid line (a) in FIG. 10 and theAPTT coagulation time is set as the vertical axis (Step S113). Theverification of the measurement result obtained by the individualidentification medium and the automatic graph preparation function canprevent the operator from erroneously inputting the measurement result,and can provide reliable results. In this case, it is preferable thatthe result is printed out from the printer 123 via the interface 122.

In a case where delayed-type measurement is subsequently performed afterthe immediate-type measurement (Step S114), the container of the mixedblood plasma (remaining specimen) after the immediate-type measurementis closed, and is incubated at 37° C. for a prescribed time in theincubator 124. However, in a case of the device having no incubator 124,the incubation is performed outside the device. Here, a case will bedescribed where the incubation is performed outside the device withoutproviding the incubator 124 for the device in order to save space andcost of the device. The device counts an incubation time starting fromthe measurement completion time. In this case, the operator canrecognize the completion time of the incubation from the operationscreen by presetting the incubation time. In addition, it is preferableto output a display informing the completion of the incubation, when theincubation completion is in time (Step S115). In this manner, theoperator can recognize a situation of the specimen during incubation,and can perform the measurement without forgetting the situation. Theoperator opens the specimen container of the mixed blood plasma whoseincubation is completed, installs the specimen container on the specimendisc 102, and presses the measurement start button. If the measurementstart button is pressed (Step S116), the mixed blood plasma ID set atthe position designated on the operation screen illustrated in FIG. 5 isread by the rotation of the specimen disc 102. The normal blood plasmaratio verified in Step S103 and the subject specimen ID are recognized.The request item is verified (Step S117), and the delayed-typemeasurement is performed (Step S118). If the measurement is completed, adelayed-type graph illustrated by a solid line (b) in FIG. 10 isprepared (Step S119), and is verified with the immediate-type result(Step S120). In this case, as illustrated in FIG. 2, the immediate-typegraph and the delayed-type graph may be combined into one, or may bedisplayed by being divided into two mutually different graphs.

As described above, according to the present embodiment, the mixed bloodplasma production, the immediate-type/delayed-type analysis, and theimmediate-type/delayed-type result verification are automaticallyperformed. Accordingly, the measurement result does not vary dependingon the skill level of the operator, and a human mistake is eliminated inhandling the specimen. Therefore, it is possible to further improvereliability.

In addition, the burden of the operator is reduced, and thus, it ispossible to quickly obtain the result.

Furthermore, it is possible to realize the automatic analysis device andthe automatic analysis method which enable automated preparation of themixed blood plasma obtained by mixing the subject blood plasma and thenormal blood plasma at a prescribed mixing ratio.

Example 2

FIG. 11 is an overall schematic configuration diagram of an automaticanalysis device of Example 2 according to another embodiment of thepresent invention. In the present embodiment, the automatic analysisdevice includes a specimen rack 201, a specimen rack supply unit 202, aspecimen rack accommodation unit 203, a transport line 204 whichtransports the specimen rack 201 to an analysis unit 210, a return line205, a rack standby unit 206, a standby unit handling mechanism 207, arack returning mechanism 208, a first reading unit (transport line) 209,and the analysis unit 210. That is, as a mechanism for mounting thespecimen container 103, the specimen container 103 is mounted on thespecimen rack 201, and various transport mechanisms for transporting thespecimen rack 201 are provided. This point is different from thataccording to Example 1. The other points are similar to those accordingto Example 1. The same reference numerals will be given to configurationelements the same as those according to Example 1, and descriptionthereof will be omitted below.

As illustrated in FIG. 11, a configuration is adopted in which aplurality of analysis units 210 can be connected to each other along thetransport line 204. However, according to the present embodiment, aconfiguration is adopted which includes at least one analysis unit forcarrying out a coagulation test. The basic configuration of the analysisunit 210 and the basic analysis flow for carrying out the coagulationtest are generally similar to those according to Example 1. However,since the specimen is supplied via the transport line 204, the presentembodiment does not have the specimen disc 102.

Hereinafter, a supply method of the specimen, which is greatly differentfrom that according to Example 1, will be described in detail.

In the automatic analysis device according to the present embodiment, atransport system of the analysis unit 210 disposed along the transportline 204 includes a second reading unit (analysis unit) 211 forverifying analysis request information relating to the specimen, a firstrack handling mechanism 212 which receives the specimen rack 201 fromthe transport line 204, a dispensing line 213 which is provided with afunction to put the specimen rack 201 on standby until the dispensingstarts, and which dispenses the specimen inside the specimen containerof the specimen rack 201, an evacuation area 214 for evacuating thespecimen rack 201 when the mixed blood plasma is prepared for the crossmixing, and a second rack handling mechanism 215 which transports thespecimen dispensed specimen rack 201 to the return line 205.

First, a specimen supply flow in general analysis, that is, whenperforming analysis with a calibrator, a control, or a general specimen,that is, a transportation procedure of the specimen racks will bedescribed with reference to FIG. 12.

If an analysis request is received via the operation unit 118, thespecimen racks 201 arrayed in the specimen rack supply unit 202 aretransferred to the transport line 204 as illustrated by an arrow (a) inFIG. 12. Thereafter, the individual identification medium (for example,a barcode) affixed to the specimen container accommodated in thespecimen rack 201 and the specimen rack 201 is read by the first readingunit (transport line) 209. The specimen rack number and the specimencontainer number are recognized (arrow (b) in FIG. 12). Thereafter, ifthe specimen read by the first reading unit (transport line) 209 isaccommodated in the specimen rack standby unit 206, and stands by theanalysis, if the specimen rack 201 is present in the dispensing line 213(arrow (c) in FIG. 12). The specimen rack 201 brought into a standbystate in a stage where the specimens of the dispensing line 213 arecompletely dispensed is sent to the analysis unit 210. The specimen racknumber and the specimen container number are recognized by the secondreading unit (analysis unit) 211 ((d) in FIG. 12). Subsequently, thespecimen rack 201 is drawn into the dispensing line 213 by the firstrack handling mechanism 212 ((e) in FIG. 12), and the specimen isdispensed by the specimen dispensing mechanism 101. In this case, if thespecimen rack 201 is not present in the dispensing line 213, thespecimen is directly transported to the dispensing line 213 withoutbeing accommodated in the specimen rack standby unit 206.

The specimen rack 201 accommodating the specimen which is completelydispensed by the specimen dispensing mechanism 101 is transported to thereturn line 205 via the second rack handling mechanism 215 ((f) in FIG.12), and is transported to the specimen rack standby unit 206 via thestandby unit handling mechanism 207 ((g) in FIG. 12). Here, the specimenrack 201 stands by the measurement result. In a case where it isdetermined that there is no retest, the specimen rack 201 is transferredto the return line 205 via the standby unit handling mechanism 207 ((h)in FIG. 12), and is transported to the specimen rack accommodation unit203 ((i) in FIG. 12).

FIG. 13 illustrates a specimen supply flow in preparing the specimen ofthe cross mixing test, that is, a transportation procedure of thespecimen racks.

If the analysis request is received from the operation unit 118, thespecimen racks 201 arrayed in the specimen rack supply unit 202 istransferred to the transport line 204 (arrow (a) in FIG. 13).Thereafter, the individual identification medium (for example, abarcode) affixed to the specimen container accommodated in specimen rack201 and the specimen rack 201 is read by the first reading unit(transport line) 209. The specimen rack number and the specimencontainer number are recognized ((b) in FIG. 13). In a case where therequest for the cross mixing test is confirmed by the first reading unit(transport line) 209, the specimen racks 201 accommodating the normalblood plasma, the subject blood plasma, and the vacant specimencontainer are all verified, and stand by the analysis after beingaccommodated in the rack standby unit 206 until there is no moreanalyzing specimen in the dispensing line 213 (arrow (c) in FIG. 13). Inthis case, even if the subject blood plasma, the normal blood plasma,and the vacant specimen container are all accommodated in the samespecimen rack, all of these may be accommodated over two or morespecimen racks.

When the dispensing line 213 has no analyzing specimen and the specimenrack 201 accommodating the subject blood plasma, the normal bloodplasma, and the vacant specimen container which are analysis targets canbe confirmed, the specimen rack accommodating the subject blood plasmaserving as the analysis target, and the specimen rack accommodating thevacant specimen container are transported to the analysis unit 210 inthis order. Then, the specimen rack number and the specimen containernumber are recognized by the second reading unit (analysis unit) 211((d) in FIG. 13). Subsequently, the specimen rack is sent to thedispensing line 213 via the second rack handling mechanism 215 ((e) inFIG. 13). Similarly to Example 1 described above, the liquid leveldetection function and the abnormal descent detection function of thespecimen dispensing mechanism 101 are used so as to confirm whether thespecimen container 103 is filled with the required amount of the subjectblood plasma and the normal blood plasma and whether the specimencontainer 103 required for preparing the mixed blood plasma is vacant.

Here, in a case where the subject blood plasma amount, the normal bloodplasma amount, and the vacant specimen container are not correctlyinstalled, the specimen container 103 is once returned to the transportline 204 via the first rack handling mechanism 212. Thereafter, thespecimen container 103 is transported to the return line 205 via thesecond rack handling mechanism 215. If the specimen container 103returns to the specimen rack accommodation unit 203, a system alarm isoutput, and the specimen preparation is canceled.

On the other hand, the specimen rack 201, in which it is confirmed thatthe subject blood plasma amount, the normal blood plasma amount, and thevacant specimen container are correctly installed, returns once to thetransport line 204 via the first rack handling mechanism 212, and istransported again to the dispensing line 213 via the second rackhandling mechanism 215. The specimen rack 201 aspirates the subjectblood plasma of the transported specimen rack 201, and subsequentlydischarges the subject blood plasma to the vacant specimen container. Inthis case, in a case where the vacant specimen container is accommodatedin another specimen rack, the specimen rack is loaded in the evacuationarea 214 disposed on the dispensing line 213, and is discharged to thevacant specimen container by the arc-shaped rotation operation insidethe horizontal plane of the specimen dispensing mechanism 101 (FIG. 14).The same operation is repeatedly performed, and the subject blood plasmaand the normal blood plasma are dispensed, thereby producing the mixedblood plasma. In this case, it is desirable to adopt a configuration inwhich the stirring mechanism 126 described in Example 1 is disposed tobe accessible to the dispensing line 213 so that the mixed blood plasmacan be mixed.

The specimen rack accommodating the prepared specimen returns to thetransport line 204 via the first rack handling mechanism 212, and issent to the return line 205 via the second rack handling mechanism. 215((g) in FIG. 13). Thereafter, the specimen rack 201 accommodating theprepared specimen is drawn into the specimen rack standby unit 206 viathe standby unit handling mechanism 207 ((h) in FIG. 13), and stands bythe analysis. Here, as illustrated in FIG. 11, in a case of a structurewhere the analysis unit 210 does not include the stirring mechanism 126,the specimen rack 201 is sent to the return line 205 via the second rackhandling mechanism 215 ((g) in FIG. 13), and returns to the specimenrack accommodation unit 203 ((g) in FIG. 13). The operator collects theprepared specimen from the returned specimen rack, installs the specimenrack 201 in the rack supply unit 202 again after stirring, and performsthe analysis of any desired item (for example, APTT) (immediate-typemeasurement). Since the analysis method is the same as that in Example1, description thereof will be omitted.

The analyzed specimen is sent to the return line 205 via the second rackhandling mechanism 215 ((g) in FIG. 13), and returns to the specimenrack accommodation unit 203 ((g) in FIG. 13). The operator collects thespecimen returning to the specimen rack accommodation unit 203, performsthe incubation at 37° C. for a prescribed time, installs the specimenagain in the specimen rack supply unit 202, and performs thedelayed-type measurement.

According to the present embodiment, in addition to the advantageouseffect of Example 1, the immediate-type measurement and the delayed-typemeasurement can be easily performed by controlling the transportingdirection of the specimen rack.

Example 3

FIG. 15 is a flowchart illustrating a process flow of an automaticanalysis device in Example 3 according to another aspect of the presentinvention. In the present embodiment, as a configuration of theautomatic analysis device itself, any configuration of Example 1 orExample 2 described above may be employed. Instead of preparing ameasurement target specimen (preparing the mixed blood plasma) insidethe specimen container, the normal blood plasma and the subject bloodplasma are directly dispensed into the reaction container so as toprepare the measurement target specimen. This point is different fromthat according to Example 1 and Example 2. That is, in the presentembodiment, the measurement is performed by adding the reagent after thenormal blood plasma and the subject blood plasma are directly dispensedinto the reaction container. Accordingly, a loss of the specimens isminimized compared to the method as in Example 1 and Example 2 where thenormal blood plasma and the subject blood plasma are mixed in a separatecontainer, and in which after the mixed blood plasma is produced, themixed blood plasma is dispensed again into the reaction container duringthe measurement.

As illustrated in FIG. 15, first, the automatic analysis device receivesa request for the cross mixing test via the operation unit 118 (StepS301). Thereafter, similarly to Example 1 and Example 2 described above,the process until the pressed “start” button illustrated in FIG. 5 isrecognized (Step S302) is the same as that according to Example 1.

As illustrated in FIG. 16, on the cross mixing measurement requestscreen according to the present embodiment, the operator sets the normalblood plasma ratio similarly to Example 1, selects and designates theanalysis item by using the test item selection/designation region 127.Here, as illustrated in FIG. 16, in this embodiment, in addition to thesubject ID, a region to which the normal blood plasma ID and theposition of the subject blood plasma/normal blood plasma can be input isdisposed on the operation screen. If the “start” button is pressed, in acase where the individual identification medium such as the barcode ofthe subject blood plasma/normal blood plasma is affixed, the specimen IDof the subject blood plasma/normal blood plasma passing in front of thereading unit 125 is recognized by the rotation of the specimen disc 102.In a case of failing to read the specimen ID or in a case where theindividual identification medium is not affixed, the specimen ID can berecognized by manually inputting the specimen ID to the column of thespecimen ID and the position of the subject blood plasma/normal bloodplasma on the operation screen in FIG. 16. In addition, in a case ofreceiving the requests from the network system using the host computer,the analysis can be performed without setting the measurement item orthe measurement condition.

If the start button is pressed (Step S302), the specimen dispensingmechanism 101 aspirates the normal blood plasma installed on thespecimen disc 102, and dispenses the normal blood plasma to the reactioncontainer 104 (Step S303). Subsequently, the subject blood plasma isaspirated and dispensed to the reaction container 104 (Step S304). Here,a dispensing procedure in the order of the normal blood plasma and thesubject blood plasma has been described, but the order of Steps S303 andS304 may be reversed. In addition, after the normal blood plasma isaspirated, the normal blood plasma may not be soon discharged to thereaction container 104. Alternatively, the subject blood plasma may beaspirated and discharged to the reaction container 104 together with thenormal blood plasma.

If the measurement is the immediate-type measurement (Step S305), thereaction container transport mechanism 112 grips the reaction container,and moves to the detecting unit 113 (Step S306). Thereafter, the reagentdispensing (Step S307) and the detection (Step S308) are performed bythe reagent dispensing mechanism 106. The processes are repeatedlyperformed until all of the specimens having the normal blood plasmaratio set on the operation screen illustrated in FIG. 16 are completelymeasured (Step S309). A graph of the immediate-type measurement resultis prepared after the measurement is completed (Step S310).

In addition, in a case where the measurement of the reaction containeris not the immediate-type measurement in Step S305, that is, in a caseof the delayed-type measurement, the reaction container 104 is moved tothe incubator 124 (Step S311), and a heating start time is stored. Allmixed blood plasmas (Step S312) having the normal blood plasma ratio seton the operation screen illustrated in FIG. 16 are repeatedly prepared,and all mixed blood plasmas are incubated. In a stage of a heatingcompletion time (Step S313), the reaction container transport mechanism112 grips the reaction container 104, and moves the reaction container104 to the detecting unit 113 (Step S314). In the present embodiment,since the incubation time can be controlled inside the automaticanalysis device, it is possible to reduce the risk of outputtingerroneous results caused by an insufficient or excessive incubationtime. Here, the time is displayed on the operation screen so as torecognize that the incubation of the cross mixing test is in progress.It is more preferable to provide a function which can flexibly set theincubation time. Thereafter, the reagent dispensing (Step S315) and thedetection (Step S316) are performed by the reagent dispensing mechanism106. The processes are repeatedly performed until all of the preparedspecimens are completely measured (Step S317). A graph of thedelayed-type measurement result is prepared after the measurement iscompleted (Step S318).

Next, in Step S319, the graph of the immediate-type measurement resultobtained in Step S310 and the graph of the delayed-type measurementresult obtained in Step S318 are verified so as to be set as a finalresult (Step S319).

As described above, according to the present embodiment, the normalblood plasma and the subject blood plasma are directly dispensed to thereaction container 104, and preparation, incubation, measurement andoutput of measurement results for the mixed blood plasma are fullyautomatically performed. In this manner, it is possible to providehighly reliable results which do not depend on an operator's skilllevel. In addition, the burden of the subject can be reduced byminimizing the amount of the specimen used for the preparation.

In addition, the present embodiment adopts a configuration in which itis possible to directly input the position of the specimen containerfilled with the normal blood plasma and the subject blood plasma.Therefore, the present embodiment is applicable to facilities operatedwithout using the specimen ID management function.

Example 4

FIG. 17 illustrates a process flow of an automatic analysis device inExample 4 according to another aspect of the present invention. InExample 1 to Example 3, the method of carrying out the cross mixing testhas been described. However, the automatic analysis device does notcarry out only the cross mixing test, but is usually used inunderstanding pathology conditions of the coagulation fibrinolysissystem, diagnosing disseminated intravascular coagulation syndrome(DIC), and confirming a thrombus treatment effect. That is, when thedelayed-type analysis is performed on the mixed blood plasma for thecross mixing test which completes the incubation, if a usual analysisrequest is made at the same time, the mixed blood plasma for the crossmixing test cannot be always immediately analyzed. Therefore, theautomatic analysis device according to the present embodiment has afunction which can select a priority of the test for each specimenclassification. This point is different from that according to Example 1to Example 3.

In order to respond to the promptness required when a blood coagulationability test is carried out before surgery in a clinical test and when atest result is reported to an outpatient on the same day, the automaticanalysis device described in the present embodiment has a function whichcan perform analysis by giving a higher priority to apromptness-requiring specimen than a usual specimen. Here, thepromptness-requiring specimens are collectively defined as an urgentspecimen, and the analysis can be performed with the higher priorityover the general specimen. On the other hand, in the mixed blood plasmafor the cross mixing test, the incubation time is controlled.Accordingly, there is a demand for an immediate measurement in a casewhere the incubation is completed for a prescribed time. Therefore, aprocess will be described with reference to FIG. 17. In the process, inorder to satisfy the needs of the operator, priorities can be selectedfor each specimen classification, and the measurement order isdetermined in accordance with the priorities. In FIG. 17, a case wherethe priorities are set to “the urgent specimen measurement>thedelayed-type cross mixing test>the general specimen measurement” will bedescribed as an example. However, the priority settings are not limitedto this form.

When the incubation of the mixed blood plasma prepared for thedelayed-type cross mixing test is completed (Step S401), in a case wherethe device is not in a standby state, the processes follow the followingflow (Step S402). It is determined whether or not there is a request forthe urgent specimen in scheduled items (Step S403). In a case wherethere is no request for the urgent specimen, the process proceeds toStep S406. The items are rescheduled so as to carry out the delayed-typecross mixing test with the higher priority over the general specimen(Step S406). However, in a case where the analysis of the urgentspecimen is requested, the analysis is performed in the order of theurgent specimen, the cross mixing test, and the general specimen.Accordingly, during the analysis of the urgent specimen, the mixed bloodplasma for the cross mixing test is once brought into a standby state inthe incubator 124 (Step S404). When the urgent specimen is completelyanalyzed (Step S405), the items are rescheduled so as to carry out thedelayed-type cross mixing test with the higher priority over the requestof the general specimen (Step S406). Here, when the incubation of themixed blood plasma prepared for the delayed-type cross mixing test iscompleted (Step S401), if the device is in the standby state, theabove-described scheduling is unnecessary. As described below, theanalysis of the cross mixing test starts.

First, the mixed blood plasma prepared for the delayed-type cross mixingtest is moved from the incubator 124 to the detecting unit 113 (StepS407). Subsequently, a reagent is dispensed to the prepared mixed bloodplasma (Step S408), and the detection is performed (Step S409). Theprocesses from Step S407 to Step S409 are repeatedly performed until allof the mixed blood plasmas prepared for the delayed-type cross mixingtest are completely analyzed. If the mixed blood plasmas are completelyanalyzed (Step S410), the result of the cross mixing test is calculatedand output (Step S411).

Thereafter, in a case where the request for the general specimen stillremains (Step S412), the general specimen is analyzed (Step S413). Ifthe general specimen is completely analyzed (Step S414), the automaticanalysis device is brought into a standby state (Step S415).

FIG. 18 is a timing chart illustrating an operation of the automaticanalysis device illustrated in FIG. 17. As illustrated in FIG. 18, in acase where the automatic analysis device itself in the standby statereceives a measurement request for the general specimen, the automaticanalysis device is brought into an operation state in order to measurethe general specimen. In this case, if a measurement request for theurgent specimen is received, the priority settings are made in advanceas described above. The highest priority is given to the urgent specimenmeasurement process, the subsequent priority is given to thedelayed-type measurement of the specimen (mixed blood plasma) for thecross mixing test, and the lowest priority is given to the generalspecimen measurement. Therefore, the highest priority is given to theurgent specimen processing. After the urgent specimen processing iscompleted, if the incubation time of the mixed blood plasma for thecross mixing test is completed again while the general specimenprocessing starts, the general specimen processing is once interrupted,and the delayed-type measurement starts. In a case where the measurementrequest for the urgent specimen is received while the delayed-typemeasurement is performed, even in a case where the highest priority isset for the urgent specimen processing, the urgent specimen processingis brought into a standby state until the delayed-type measurement iscompleted. After the cross mixing test is completed, the urgent specimenis analyzed.

As described above, according to the present embodiment, in addition tothe advantageous effect according to Example 1 and Example 2, theoperator presets a priority for each specimen, such as the generalspecimen and interruption processing for the urgent specimen. In thismanner, based on the set priority, the automatic analysis device canperform the analysis. Therefore, a human mistake can be minimized inerroneously handling the specimen, and the automatic analysis device canbe efficiently operated.

Example 5

FIG. 19 is a flowchart illustrating a process flow of an automaticanalysis device in Example 5 according to another aspect of the presentinvention. The present embodiment is different from Example 1 to Example4 described above in that the reagent is managed based on the number ofmixed blood plasma specimens. The configurations other than the reagentmanagement method are the same as those according to Example 1 toExample 4, and thus, description thereof will be omitted below.

For example, in the cross mixing test, seven measurement values aretreated as one set of results. Accordingly, it is necessary to securethe reagent in the same lot (preferably, the same bottle) for one set ofmeasurements. In particular, in a case where the measurement item isAPTT, the calibration is not performed. Consequently, the measurementresults tend to vary in the reagent in the different lot. In addition,even in the same lot, the reagent inside the reagent container (reagentbottle) which is stored in the device for awhile and the reagent in anewly opened reagent container (reagent bottle) are likely to vary.Therefore, in this automatic analysis device according to the presentembodiment, in a case where the analysis request for the cross mixingtest is confirmed, it is important to secure the reagent which can beused in performing one set of measurements at least once. As illustratedin FIG. 19, if the immediate-type analysis request is received (StepS501), the control unit 120 confirms the required number of tests (thenumber of prepared mixed blood plasmas) and the remaining amount of thereagent. That is, it is determined whether or not a relationshipsatisfies “the number of mixed blood plasma specimens the number ofreagent remaining tests” (Step S502). In a case where the determinationresult in Step S502 is “NO”, that is, in a case where the number ofmixed blood plasma specimens exceeds the number of reagent remainingtests, the process proceeds to Step S504, and an alarm is displayed onthe display unit 118 c. In addition, in a case where the determinationresult in Step S502 shows that the number of mixed blood plasmaspecimens is equal to or smaller than the number of reagent remainingtests, the process proceeds to Step S503, and cross mixing test iscarried out (analysis is performed).

In addition, in a case where a plurality of reagent bottles having thesame item are installed, the control unit 120 controls the bottles so asnot to collectively analyze at least one set of measurements. Forexample, when the number of remaining tests of a bottle 1 is “3 tests”and the number of remaining tests of a bottle 2 is “100 tests”, in acase where the cross mixing test is requested at 7 points (7conditions), “the number of mixed blood plasma specimens (seven) thenumber of reagent remaining tests of the bottle 1” is satisfied.Accordingly, the analysis in the bottle 1 is cancelled, and the numberof remaining tests in the bottle 2 is verified. In a case of the bottle2, “the number of mixed blood plasma specimens (seven) the number ofreagent remaining tests of the bottle 2” is satisfied. Accordingly, thecross mixing test (analysis) is carried out. In addition, in a casewhere there is no reagent bottle which can be analyzed, a system alarmis output, and the analysis start is canceled (Step S504).

According to the present embodiment, it is possible to perform analysisusing the reagent in the same bottle without causing the reagentshortage in the middle of the analysis with regard to one set of crossmixing tests. In addition, this configuration can provide highlyreliable results.

Example 6

FIG. 20 is a flowchart illustrating a process flow of an automaticanalysis device in Example 6 according to another aspect of the presentinvention. In the present embodiment, the method of preparing the mixedblood plasma is different from the above-mentioned methods according toExample 1 to Example 5. In addition, the configuration of the automaticanalysis device and the flow of the general coagulation test are thesame as those according to Example 1 or Example 2, and thus, repeateddescription will be omitted below. In addition, with regard to themethod of preparing the specimen, points the same as those according toExample 1 will be briefly described as much as possible.

As illustrated in FIG. 5, Example 1 and Example 2 described above adopta configuration in which the required normal blood plasma amount and therequired subject blood plasma amount are displayed on the display unit118 c and the operator is informed of the displayed information so as toavoid the risks of the specimen shortage during the preparation.However, in a case where the normal blood plasma amount and/or thesubject blood plasma amount are insufficient due to a mistake of theoperator, the specimen shortage occurs during the preparation, and theprepared specimen become useless. Therefore, according to the automaticanalysis device of the present embodiment, even in a case where thenormal blood plasma and/or the subject blood plasma to be prepared areinsufficient as described above, the specimen is no longer useless,thereby enabling the measurement to be effectively performed.

As illustrated in FIG. 20, if the automatic analysis device receives therequest for the cross mixing test (Step S601) and the measurement itemand the normal blood plasma ratio are set, the analysis operationcontrol unit 120 a performs the following processes. That is, theanalysis operation control unit 120 a calculates the normal blood plasmaamount and the subject blood plasma amount which are required for themeasurement, determines each of the normal blood plasma amount and thesubject blood plasma amount which vary depending on each condition, andcontrols the operation of the specimen dispensing mechanism 101.

Subsequently, if the “start” button on the operation screen illustratedin FIG. 5 is pressed, the analysis operation control unit 120 arecognizes that the “start” button is pressed (Step S602). Subsequently,the presence or absence of the vacant specimen container is confirmed(Step S603). The method of confirming the presence or absence of thevacant specimen container is the same as that in the process (Example 1)of Step S103 in FIG. 3.

In Step S604, it is determined whether or not the number of the vacantspecimen containers obtained by performing Step S603 is N (N is anatural number) or more. For example, in this case, N is set to seven,which is the number of the vacant specimen containers corresponding tothe normal blood plasma ratio set on the operation screen illustrated inFIG. 5. As a determination result, in a case where the required numberof vacant specimen containers is not installed at a predeterminedposition, the preparation of the specimen is stopped, and a system alarmis displayed on the display unit 118 c (Step S605). On the other hand,as a determination result, in a case where the vacant specimen containeris installed at the predetermined position, the process proceeds to StepS606 so as to check the blood plasma amount by using the liquid leveldetection function of the specimen dispensing mechanism 101.

Incidentally, 3 points at the minimum are recommended for the number ofmeasurements in the cross mixing test. In other words, the cross mixingtest can be carried out if the number is 3 points or more. FIG. 21illustrates a display example of the operation screen when the crossmixing test is requested according to the present embodiment. Asillustrated in FIG. 21, the cross mixing test measurement request screenhas a region in which the priorities of the normal blood plasma ratiocan be selected. In the example illustrated in FIG. 21, the input can bemade in three sequential stages from the highest priority. That is, thepriority set in the priority setting region has a relationship of“priority 1>priority 2>priority 3”. In addition, the example shows astate where the priority 1 is set when the normal blood plasma ratio is0%, 50%, and 100%, the priority 2 is set when the normal blood plasmaratio is 10% and 20%, and the priority 3 is set when the normal bloodplasma ratio is 80% and 90%. These set priorities are stored in thestorage unit 119.

In addition, FIGS. 22 to 24 illustrate a relationship between the normalblood plasma amount and the subject blood plasma amount which correspondto the respective normal blood plasma ratios. As illustrated in FIG. 22,under the seven conditions of the normal blood plasma ratio of 0%, 10%,20%, 50%, 80%, 90%, 100%, in a case where 200 μL of the mixed bloodplasma is produced and the cross mixing test is carried out, eachrequired amount of the normal blood plasma and the subject blood plasmais 700 μL or more. Here, a method for obtaining an effective analysisresult will be described. The method uses a small amount of blood plasmaeven in a case where any one or both of these do not satisfy therequired amount.

Here, referring back to FIG. 20, in Step S607, it is determined whetheror not the normal blood plasma amount is equal to or more than X_(N) andwhether or not the subject blood plasma amount is equal to or more thanY_(N). Here, X_(N) is 700 μL in the example illustrated in FIG. 22, andY_(N) is similarly 700 μL. As a determination result, in a case whereany one or both of “the normal blood plasma amount X_(N)” and “thesubject blood plasma amount Y_(N)” do not satisfy the condition, thatis, in a case where the blood plasma amount does not satisfy therequired amount, the process proceeds to Step S608.

In Step S608, in order to change the number of measurement points, thepriority set for each of the normal blood plasma ratios stored in thestorage unit 119 is verified, and the condition corresponding topriority 3 is excluded, thereby recalculating the blood plasma amount.In Step S609, it is determined whether or not “the normal blood plasmaamount≥(X_(N)−X_(P3))” and “the subject blood plasmaamount≥(Y_(N)−Y_(P3))” are satisfied. Here, the normal blood plasmaamount (X_(N)−X_(P3)) when the measurement is performed under thecondition excluding the priority 3 is 360 μL, the subject blood plasmaamount (Y_(N)−Y_(P3)) when the measurement is performed under thecondition excluding the priority 3 is 640 μL (FIG. 23). As adetermination result, in a case where any one or both of “the normalblood plasma amount≥(X_(N)−X_(P3))” and “the subject blood plasma amount(Y_(N)-Y_(P3))” do not satisfy the condition, the process proceeds toStep S610. On the other hand, as a determination result, in a case wherethe above-described condition is satisfied, the process proceeds to StepS613.

In Step S610, the blood plasma amount at the time of measurement isrecalculated under the condition that only the priority 1 is set, thatis, under the condition that the conditions of priority 2 and priority 3are excluded. Here, the normal blood plasma amount of 300 μL and thesubject blood plasma amount of 300 μL are obtained as a recalculatedblood plasma amount (FIG. 24). Next, the process proceeds to Step S611so as to determine whether “the normal blood plasmaamount≥(X_(N)−X_(P3)−X_(P2))” and “the subject blood plasma amount to beexamined (Y_(N)−Y_(P3)−Y_(P2))” are satisfied. As a determinationresult, in a case where any one or both of “the normal blood plasmaamount (X_(N)−X_(P3)−X_(P2))” and “the subject blood plasma amount to beexamined≥(Y_(N)−Y_(P3)−Y_(P2))” do not satisfy the condition, theprocess proceeds to S612. A system alarm is output to the display unit118 c, and preparing the mixed blood plasma is stopped. On the otherhand, as a determination result, in a case where the above-describedcondition is satisfied, the process proceeds to Step S613.

In Step S613, the analysis operation control unit 120 a controls thespecimen dispensing mechanism 101 and the reagent dispensing mechanism106 so as to start dispensing the normal blood plasma and the subjectblood plasma. Dispensing the normal blood plasma and the subject bloodplasma is similar to that according to Example 1 described above, andthus, description thereof will be omitted here. If all of the normalblood plasma and the subject blood plasma are completely dispensed (StepS614), the analysis operation control unit 120 a controls the stirringmechanism 126 so as to stir the mixed blood plasma (Step S615). Afterthe mixed blood plasma is stirred, the analysis is performed.

In FIG. 20, a case where the priorities are set in three stages has beendescribed as an example. However, without being limited thereto, thepriorities can be optionally set.

According to the present embodiment, in addition to the advantageouseffect of Example 1 and Example 2 described above, it is possible toobtain effective cross mixing measurement results, even in a case wherethe condition does not satisfy the normal blood plasma amount and/or thesubject blood plasma amount which are for the measurement correspondingto the initially set normal blood plasma ratio.

The present invention is not limited to the above-described embodiments,and includes various modifications. For example, the above-describedembodiments have been described in detail in order to facilitate theunderstanding of the present invention, and the present invention is notnecessarily limited to those including all of the describedconfigurations. In addition, a configuration of one embodiment can bepartially substituted with a configuration of the other embodiment.Alternatively, the configuration of the other embodiment can be added tothe configuration of one embodiment. Alternatively, additions,omissions, and substitutions of the configuration of the otherembodiment can be made for a portion of the configuration in eachembodiment.

REFERENCE SIGNS LIST

-   100: AUTOMATIC ANALYSIS DEVICE-   101: SPECIMEN DISPENSING MECHANISM-   101 a: SPECIMEN DISPENSING PROBE-   102: SPECIMEN DISC-   103: SPECIMEN CONTAINER-   104: REACTION CONTAINER-   105: SPECIMEN SYRINGE PUMP-   106: REAGENT DISPENSING MECHANISM-   106 a: REAGENT DISPENSING PROBE-   107: REAGENT DISC-   108: REAGENT CONTAINER-   108 a: REAGENT-   109: REAGENT TEMPERATURE RAISING MECHANISM-   110: REAGENT SYRINGE PUMP-   111: REACTION CONTAINER STOCK UNIT-   112: REACTION CONTAINER TRANSPORT MECHANISM-   113: DETECTING UNIT-   114: REACTION CONTAINER INSTALLATION UNIT-   115: LIGHT SOURCE-   116: DETECTOR (LIGHT RECEIVING UNIT)-   117: REACTION CONTAINER DISPOSAL UNIT-   118: OPERATION UNIT-   118 a: MOUSE-   118 b: KEYBOARD-   118 c: DISPLAY UNIT-   119: STORAGE UNIT-   120: CONTROL UNIT-   120 a: ANALYSIS OPERATION CONTROL UNIT-   120 b: CALCULATION UNIT-   121: A/D CONVERTER-   122: INTERFACE-   123: PRINTER-   124: INCUBATOR-   125: READING UNIT-   126: STIRRING MECHANISM-   127: TEST ITEM SELECTION/DESIGNATION REGION-   201: SPECIMEN RACK-   202: SPECIMEN RACK SUPPLY UNIT-   203: SPECIMEN RACK ACCOMMODATION UNIT-   204: TRANSPORT LINE-   205: RETURN LINE-   206: SPECIMEN RACK STANDBY UNIT-   207: STANDBY UNIT HANDLING MECHANISM-   208: RACK RETURNING MECHANISM-   209: FIRST READING UNIT (TRANSPORT LINE)-   210: ANALYSIS UNIT-   211: SECOND READING UNIT (ANALYSIS UNIT)-   212: FIRST RACK HANDLING MECHANISM-   213: DISPENSING LINE-   214: EVACUATION AREA-   215: SECOND RACK HANDLING MECHANISM

The invention claimed is:
 1. An automatic analysis device comprising: aspecimen container holding unit that accommodates and holds a pluralityof specimen containers; a specimen dispensing mechanism that dispensesonly subject blood plasma, dispenses only normal blood plasma, anddispenses both the subject blood plasma and the normal blood plasma at afirst predetermined mixing ratio of the subject blood plasma and thenormal blood plasma to a plurality of vacant specimen containers,respectively; a plurality of reaction containers to which the specimendispensing mechanism respectively dispenses the subject blood plasmaalone, the normal blood plasma alone, and both the subject blood plasmaand the normal blood plasma at the first predetermined mixing ratioafter they are prepared in the plurality of vacant specimen containers,respectively; a reagent dispensing mechanism that dispenses a reagent toeach of the plurality of reaction containers; a measurement unit thatirradiates each of the plurality of reaction containers with lightemitted from a light source, and that measures a plurality ofcoagulation times, respectively, based on obtained scattered lightand/or transmitted light; and a control unit configured to control thespecimen dispensing mechanism to perform an immediate-type measurementby dispensing the subject blood plasma alone, the normal blood plasmaalone, and both the subject blood plasma and the normal blood plasma atthe first predetermined mixing ratio immediately after they are preparedin the plurality of vacant specimen containers into the plurality ofreaction containers, respectively, to measure immediate-type coagulationtimes, and configured to control the specimen dispensing mechanism toautomatically perform a delayed-type measurement by dispensing thesubject blood plasma alone, the normal blood plasma alone, and both thesubject blood plasma and the normal blood plasma at the firstpredetermined mixing ratio into another plurality of reactioncontainers, respectively, after a predetermined time elapses to measuredelayed-type coagulation times.
 2. The automatic analysis deviceaccording to claim 1, wherein the control unit that controls thespecimen dispensing mechanism to perform the immediate-type measurementand the delayed-type measurement for at least one mixture of both thesubject blood plasma and the normal blood plasma at least at one otherpredetermined mixing ratio different from the first predetermined mixingratio.
 3. The automatic analysis device according to claim 1, whereinthe specimen container holding unit is a specimen rack that contains thesubject blood plasma alone, the normal blood plasma alone, and both thesubject blood plasma and the normal blood plasma at the firstpredetermined mixing ratio, wherein the automatic analysis devicefurther comprises a specimen rack supply unit that accommodates aplurality of the specimen racks; a transport line that transports thespecimen rack from the specimen rack supply unit to the measurementunit; and a return line that transports the specimen rack from themeasurement unit to a specimen rack accommodation unit.
 4. The automaticanalysis device according to claim 1, further comprising: a display unitthat graphically displays the plurality of coagulation times for theimmediate-type measurement and the delayed-type measurement.
 5. Theautomatic analysis device according to claim 1, further comprising: anincubator that warms the reaction containers containing the subjectblood plasma alone, the normal blood plasma alone and both the subjectblood plasma and the normal blood plasma at the first predeterminedmixing ratio at a predetermined temperature for a predetermined amountof time.
 6. The automatic analysis device according to claim 5, whereinthe reagent dispensing mechanism dispenses the reagent to the reactioncontainers containing the subject blood plasma alone, the normal bloodplasma alone and both the subject blood plasma and the normal bloodplasma at the first predetermined mixing ratio which are warmed for thepredetermined amount time, and the measurement unit measures thecoagulation time.
 7. The automatic analysis device according to claim 4,wherein information of the subject blood plasma alone, the normal bloodplasma alone and both the subject blood plasma and the normal bloodplasma at the first predetermined mixing ratio is managed by usingindividual identification media.
 8. The automatic analysis deviceaccording to claim 2, further comprising: a liquid level detectingmechanism that confirms an amount of the subject blood plasma, an amountof the normal blood plasma, and a presence of the plurality of vacantspecimen containers in advance.
 9. The automatic analysis deviceaccording to claim 8, wherein priorities are set in advance for thesubject blood plasma alone, the normal blood plasma alone, and the boththe subject blood plasma and the normal blood plasma at the firstpredetermined mixing ratio, and wherein in a case where a shortage ofthe amount of the subject blood plasma and/or the amount of the normalblood plasma is predicted, in order to measure the coagulation times,based on the set priorities, a combination is determined among the firstpredetermined mixing ratio and the at least one other predeterminedmixing ratio.
 10. The automatic analysis device according to claim 2,wherein a remaining amount of the reagent is managed for each reagentcontainer, and a reagent container to be used is controlled inaccordance with a number of reaction containers to be used.
 11. Theautomatic analysis device according to claim 1, wherein the measurementunit gives a priority to and measures a specimen according to thepriority.
 12. The automatic analysis device according to claim 11,further comprising: an operation unit that presets priorities for anurgent specimen, a general specimen, and a specimen containing both thesubject blood plasma and the normal blood plasma at the firstpredetermined mixing ratio for measuring the coagulation times.
 13. Theautomatic analysis device according to claim 9, further comprising: astorage unit that stores each of the priorities; and a control unit thatperforms control so that the specimen corresponding to the prioritystored in the storage unit is transported to the measurement unit via aspecimen disc or a transport line.
 14. The automatic analysis deviceaccording to claim 1, wherein the specimen container holding unit is aspecimen disc that causes the subject blood plasma, the normal bloodplasma, and both the subject blood plasma and the normal blood plasma atthe first predetermined mixing ratio to be contained in the vacantspecimen containers which are annularly arrayed separately from eachother.
 15. An automatic analysis method of an automatic analysis devicewhich has at least a specimen container holding unit that accommodatesand holds a plurality of specimen containers, a specimen dispensingmechanism, a reagent dispensing mechanism, a measurement unit, and acontrol unit, the method comprising: dispensing, by the specimendispensing mechanism, only subject blood plasma, only normal bloodplasma, and both the subject blood plasma and the normal blood plasma ata first predetermined mixing ratio of the subject blood plasma and thenormal blood plasma to a plurality of vacant specimen containers,respectively, accommodated in the specimen container holding unit;dispensing the subject blood plasma alone, the normal blood plasmaalone, and both the subject blood plasma and the normal blood plasma atthe first predetermined mixing ratio after they are prepared in theplurality of vacant specimen containers to a plurality of reactioncontainers, respectively; dispensing, by the reagent dispensingmechanism, a reagent to each of the plurality of reaction containers;irradiating each of the plurality of reaction containers with lightemitted from a light source, and measuring a plurality of coagulationtimes, respectively, based on obtained scattered light and/ortransmitted light; and controlling the specimen dispensing mechanism toperform an immediate-type measurement by dispensing the subject bloodplasma alone, the normal blood plasma alone, and both the subject bloodplasma and the normal blood plasma at the first predetermined mixingratio immediately after they are prepared in the plurality of vacantspecimen containers into the plurality of reaction containers,respectively, to measure immediate-type coagulation times, and thatcontrolling the specimen dispensing mechanism to automatically perform adelayed-type measurement by dispensing the subject blood plasma alone,the normal blood plasma alone, and both the subject blood plasma and thenormal blood plasma at the first predetermined mixing ratio into anotherplurality of reaction containers, respectively, after a predeterminedtime elapses to measure delayed-type coagulation times.
 16. Theautomatic analysis method according to claim 15, further comprising:causing a display unit to graphically display the plurality ofcoagulation times for the immediate-type measurement and thedelayed-type measurement.
 17. The automatic analysis method according toclaim 15, further comprising: warming the reaction containers containingthe subject blood plasma alone, the normal blood plasma alone and boththe subject blood plasma and the normal blood plasma at the firstpredetermined mixing ratio at a predetermined temperature for apredetermined amount of time; and dispensing the reagent to the reactioncontainers after being warmed for the predetermined amount of time, andmeasuring the coagulation times.
 18. The automatic analysis methodaccording to claim 15, further comprising: presetting priorities for thesubject blood plasma alone, the normal blood plasma alone, and both thesubject blood plasma and the normal blood plasma at the firstpredetermined mixing ratio and at least one mixture of both the subjectblood plasma and the normal blood plasma at least at one otherpredetermined mixing ratio different from the first predetermined mixingratio; and determining a combination among the first predeterminedmixing ratio and the at least one other predetermined mixing ratio inorder to measure the coagulation times, based on the set priorities. 19.The automatic analysis method according to claim 15, further comprising:presetting priorities for an urgent specimen, a general specimen, and aspecimen containing both the subject blood plasma and the normal bloodplasma at the first predetermined mixing ratio for measuring thecoagulation time; and changing an analysis order in accordance with theset priorities.
 20. An automatic analysis device comprising: a specimencontainer holding unit that accommodates and holds a plurality ofspecimen containers; a specimen dispensing mechanism that dispenses onlysubject blood plasma, dispenses only normal blood plasma, and dispensesboth subject blood plasma and normal blood plasma at a firstpredetermined mixing ratio of the subject blood plasma and the normalblood plasma to a plurality of vacant specimen containers, respectively;a reagent dispensing mechanism that dispenses a reagent to each of aplurality of reaction containers to which the specimen dispensingmechanism respectively dispenses the subject blood plasma alone, thenormal blood plasma alone, and both the subject blood plasma and thenormal blood plasma at the first predetermined mixing ratio after theyare prepared in the plurality of vacant specimen containers,respectively; a measurement unit that irradiates each of the pluralityof reaction containers with light emitted from a light source, and thatmeasures a plurality of coagulation times, respectively, based onobtained scattered light and/or transmitted light; and a control unitconfigured to control the specimen dispensing mechanism to perform animmediate-type measurement by dispensing the subject blood plasma alone,the normal blood plasma alone, and both the subject blood plasma and thenormal blood plasma at the first predetermined mixing ratio immediatelyafter they are prepared in the plurality of vacant specimen containersinto the plurality of reaction containers, respectively, to measureimmediate-type coagulation times, and configured to control the specimendispensing mechanism to automatically perform a delayed-type measurementby dispensing the subject blood plasma alone, the normal blood plasmaalone, and both the subject blood plasma and the normal blood plasma atthe first predetermined mixing ratio into another plurality of reactioncontainers, respectively, after a predetermined time elapses to measuredelayed-type coagulation times.